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Completed

NCT Number: NCT00886418

Influence of Muscle Relaxation on a Closed-loop Anesthesia System

Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scheduled for a surgical procedure which not require a myorelaxation

Exclusion criteria

  • age less than 18 years,
  • ASA III and above,
  • pregnant woman
  • combined general and regional anesthesia,
  • history of prolonged myorelaxation due to a decrease in cholinesterase,
  • patient with a known lack in cholinesterase,
  • history of cerebral or psychiatric central,
  • allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
  • known hypersensitivity to remifentanil or to an other derivative of fentanyl,
  • presence of a pacemaker,
  • psychotropic or agonist-antagonist morphine treatment,
  • planned post-operative sedation.

Treatment and study plan

muscle relaxant

Drug

muscle relaxant administration throughout anesthesia

normal saline

Drug

no muscle relaxant throughout anesthesia (normal saline infused as a placebo)

Primary outcomes

  1. propofol dose

    Time frame: one hour anesthesia

Secondary outcomes

  1. remifentanil dose

    Time frame: one hour anesthesia

  2. number of automatic modifications of the propofol and remifentanil concentrations

    Time frame: one hour anesthesia

  3. number of patients' movements

    Time frame: one hour anesthesia

  4. number of hemodynamic abnormalities requiring treatment

    Time frame: one hour anesthesia

  5. time to wake up

    Time frame: end of anesthesia

  6. intraoperative awareness

    Time frame: postoperative day 1 or 2

  7. performance of the closed-loop system

    Time frame: one hour anesthesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

Acronym: Drone-Curare

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2009
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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